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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The kits allow for access to the subarachnoid space or the lateral ventricles of the brain. The kits are intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF, and to monitor ICP.

Integra LifeSciences Corp. d.b.a. Integra Pain Management

Class I - Dangerous

Integra is recalling certain lots of Cranial Access Kit due to a possibility that the seal integrity of the sterile package may become compromised during shipping.

Sep 4, 2013 Diagnostic Equipment Nationwide View Details →

Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 8881580123 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices

Covidien

Class I - Dangerous

Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin

Aug 16, 2013 Surgical Instruments Nationwide View Details →

Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer. The Datex-Ohmeda Tec 6 Plus and Tec 6 Plus NAD Variant is an electronic vaporizer which delivers the anesthetic agent desflurane. The Tec 6 Plus attaches only to Datex-Ohmeda anesthesia machines equipped with the proprietary Selectatec manifold. The Tec 6 Plus NAD Variant attaches only to NAD anesthesia machines equipped with the NAD exclusion type manifold.

GE Healthcare

Class I - Dangerous

GE Healthcare has recently become aware of a potential safety issue involving the pre-operative check, low pressure leak test at 1% dial setting of the Tec 6 and Tec 6 Plus Vaporizers. The user manual pre-operative check, low pressure leak test may not detect the full range of leaks from seal wear degradation in the vaporizers. If the leak is not detected, it will result in fresh gas leaking to

Jul 29, 2013 Infusion Pumps Nationwide View Details →

Microscan Synergies Plus Negative Urine Combo 5 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.

Siemens Healthcare Diagnostics

Class I - Dangerous

Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.

Aug 21, 2013 Infusion Pumps Nationwide View Details →

Microscan Synergies Plus Negative Urine Combo 2 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.

Siemens Healthcare Diagnostics

Class I - Dangerous

Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.

Aug 21, 2013 Infusion Pumps Nationwide View Details →

Microscan Synergies Plus Negative Breakpoint Combo 7 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.

Siemens Healthcare Diagnostics

Class I - Dangerous

Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.

Aug 21, 2013 Infusion Pumps Nationwide View Details →

Xlumena brand NAVIX Access Device, Model/Catalogue Number: NVX-10-03, Part Number: FG-00666, Product is manufactured and distributed by Xlumena, Inc., Mountain View, CA The NAVIX Access Device is a multi-lumen balloon catheter with a trocar, anchor balloon, and dilation balloon that creates and dilates a tract across tissue planes. The NAVIX Access Device is indicated for use as an accessory to cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst, when it is visibly bulging into the gastrointestinal tract during endoscopic procedures.

Xlumena

Class I - Dangerous

A complaint investigation has found that product fractures can occur at the distal end of the catheter under load.

Apr 17, 2013 Diagnostic Equipment View Details →

Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill Product ID: 8881570121 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices

Covidien

Class I - Dangerous

Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin

Aug 16, 2013 Surgical Instruments Nationwide View Details →

Tempa DOT Single-Use Clinical Thermometer Medical Indicators Made in U.S.A. by Medical Indicators, Inc. 16 Thomas J Rhodes Industrial Drive, Hamilton, NJ 08619 USA Phone 1.888.737.1601 www.medicalindicators.com Per 3M website (this product line was recently bought by Medical Indicators from 3M) and labeling in 806, TempaDOT thermometers are individually wrapped, single-use, disposable clinical thermometers for oral or axillary use.

Medical Indicators

Class I - Dangerous

TempaDot products may have been mislabeled.

Jul 10, 2013 Diagnostic Equipment Nationwide View Details →

Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-100ES, 621-200ES, 621-300ES, and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.

B Braun Medical

Class I - Dangerous

This notice is being provided in follow up to the field correction initiated by B. Braun Medical Inc. on 26 August, 2011 due to an issue in the Outlook ES Safety Infusion System where the Care Area can inadvertently be exited thereby removing DoseGuard dose limit protection. This occurs when a sequence of HOLD - HOLD key strokes are performed on the pump key panel while the user is in the Dose Dat

Oct 31, 2012 Infusion Pumps Nationwide View Details →

MicroscanrapID/S panels NC3.11 Sold in Japan only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.

Siemens Healthcare Diagnostics

Class I - Dangerous

Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.

Aug 21, 2013 Infusion Pumps Nationwide View Details →

Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-100ES, and 621-200ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.

B Braun Medical

Class I - Dangerous

B. Braun Medical Inc. is informing our customers of a field correction previously performed to address the loss of the drug library in the Outlook Pump Models 620-100 and 620-200. This could have occurred after periods of lost DC (battery) power or out of tolerance low power. This could have led to a delay in therapy, or to delivery of an over or under-dose of a therapy if the user was to rely on

Dec 5, 2012 Infusion Pumps Nationwide View Details →